Environmental Monitoring Specialist

3 weeks ago

Summit, New Jersey, United States Bristol-Myers Squibb Full time

Job Summary:

The Environmental Monitoring Specialist will work with the team to perform routine and non-routine environmental monitoring in GMP areas of Summit West CAR-T Manufacturing and Warehouses.

Responsibilities:

  • Collect environmental monitoring samples for controlled, non-classified areas as well as controlled non-aseptic and aseptic processing areas of manufacturing.
  • Perform sample analysis, printing of batch labels, and creating EM sample plans.
  • Retrieve sample plates, sanitize EM equipment, and document in logbooks.
  • Deliver samples to QC Microbiology.
  • Work in compliance with established safe work practices and procedures; properly use personal protection and safety equipment as required by Bristol Myers Squibb.
  • Report any injury or illness immediately and notify BMS of any hazards, unsafe acts, or conditions in the workplace.
  • Perform routine processes following written instructions (SOPs) in support of the production of pharmaceutical products with adherence to FDA or cGMP guidance.
  • Work in an aseptic production environment.
  • Must be able to wear appropriate clean room attire (i.e., surgical masks, sterile gown) and all Personal Protective Equipment (PPE).
  • Accurately complete all EM sampling documentation.
  • Operate and maintain equipment and work area to ensure cleanliness and safety following GMPs and SOPs.
  • Ensure that materials and equipment in the Manufacturing area are maintained in accordance with GMPs and SOPs.
  • Contribute to achieving continuous improvement.
  • Must work independently with minimal supervision.
  • Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown.
  • Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU, and other global regulatory requirements at all times.
  • Follow directions properly and work cooperatively as an individual contributor and as a team member.
  • Communicate effectively with Manufacturing Operations peers, cross-functional peers, and management.
  • Assist in troubleshooting and solving problems that may come up in the day-to-day operation of the department.
  • Perform Environmental Monitoring on a routine and non-routine basis for all S12 & S16 GMP manufacturing and associated warehouse areas.
  • Assist with investigations & CAPAs associated with EM excursions.
  • Perform all other duties as assigned.

Requirements:

  • Flexible with the ability to adapt, respond quickly, and manage change in a fast-paced environment.
  • Demonstrates effective written and verbal communication skills.
  • Able to utilize a computer for training.
  • Position requires the ability to wear aseptic gowning (ISO7/ISO8).
  • Knowledge and understanding of basic math skills to perform calculations.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • Demonstrates ability to follow detailed directions in a manufacturing cGMP environment.
  • Clear and accurate documentation of all necessary EM sampling information.
  • Thorough understanding of regulatory requirements for cGMP manufacturing facility.

Basic Requirements:

  • Requires a High School diploma or equivalent. Associate or bachelor's degree in a scientific discipline preferred.
  • 1-2 years of demonstrated work experience in a regulated industry.

Working Conditions:

  • The incumbent will be required to wear a uniform/PPE to work in the manufacturing or laboratory environment.
  • The incumbent may be required to stand and walk for an extended amount of time.
  • Start and end times may shift due to needs of production support.
  • Must be able to perform tasks with hands/arms raised above head for short periods of time.
  • Repetitive hip and upper body twisting movements.
  • Able to lift 25 pounds on a continuous basis.
  • The incumbent may be required to work on hazardous materials.
  • Flexibility with schedule (weekends, holidays, extended hours, and rotating/staggered shifts) is an absolute must.
  • Flexible to work shift structures.
  • Position requires the ability to wear aseptic gowning (ISO7/ISO8) for long periods of time.
  • Change to work timings and assigned tasks may occur at very short notice to support business needs.
  • Works in production environment with potential exposure to latex and sporicidal agents.
  • Potential exposure to noise and equipment hazards (i.e., vacuum pumps, pressurized vessels), dangerous materials (i.e., Chemicals, solvents), and strong odors.
  • Need to be able to read, write, and understand English.
  • This position requires the passing of a pre-employment drug screen in compliance with federal drug testing rules.

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